Study of WPV01 Compared With Placebo in Patients With Mild/Moderate COVID-19 Infection

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of WPV01 in Patients With Mild/Moderate COVID-19 Infection

A randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of WPV01 in patients with mild/moderate COVID-19 infection

Study Overview

• Status: Completed
• Conditions: COVID-19 Infection
• Intervention / Treatment: Drug: Placebo; Drug: WPV01

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • Shulan(Hangzhou) Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants ≥18 years of age when signing ICF;
2. Initial onset at least 1 of 11 COVID-19 symptoms within 48 hours before randomization;
3. Within three days before randomization, the RT-PCR test of specimens such as nasal and pharyngeal swabs must be positive for SARS-CoV-2 or the rapid antigen test must be positive, and also the patiets should meet the diagnostic criteria for mild or moderate cases as defined in the Diagnosis and Treatment Protocol for COVID-19 (Trial Version 10) issued by the National Health Commission of China;
4. Fertile participants must agree to take effective contraceptive measures;
5. Participants who understand and agree to comply with planned study procedures，voluntarily participate in this clinical trial and sign an informed consent form.

Exclusion Criteria:

1. Known allergy to any ingredient in the study treatment drug;
2. Patients who meet the diagnostic criteria for severe or critical cases of COVID-19 as defined in the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 10) issued by the National Health Commission of China at the time of randomization;
3. Obvious abnormal liver function (ALT or AST ≥ 3ULN, or total bilirubin ≥1.5ULN);
4. On dialysis or combined with moderate to severe kidney injury;
5. Patients with compromised immune system;
6. Patients with acute exacerbation of chronic respiratory disease at screening, including bronchial asthma, chronic obstructive pulmonary disease;
7. Patients with suspected or confirmed concurrent active systemic infection other than COVID-19 at screening;
8. Any comorbidity requiring surgery within 14 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator;
9. Has received or is expected to receive COVID-19 monoclonal antibody or convalescent COVID-19 plasma during study treatment;
10. Has received treatment with antivirals against SARS-CoV-2 within 14 days prior to randomization;
11. Has received any novel coronavirus infection vaccine within 1 week prior to randomization;
12. Current or expected use of strong CYP3A4 inducers, inhibitors or medications that are highly dependent on CYP3A4 for clearance;
13. Difficulty swallowing or a history of gastrointestinal disorders that severely interfere with drug absorption;
14. BMI≥30 kg/m2;
15. Pregnant, lactating women or those with a positive pregnancy test;
16. Previous administration with any investigational drug within 3 months before the study drug administration;
17. Patients who are judged by the investigator to be unsuitable to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo tablets
Experimental: WPV01	Drug: WPV01; WPV01 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in viral load	Change of viral load compared to the baseline	Baseline through Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the total score of COVID-19 symptoms	Change in the total score of COVID-19 symptoms compared to the baseline	Baseline through Day 14
Change in the score of each COVID-19 symptom	Change in the score of each COVID-19 symptom compared to the baseline	Baseline through Day 14
Change of EuroQol Questionnaire - 5 Dimension (EQ-5D)	Change of EuroQol Questionnaire - 5 Dimension (EQ-5D) compared to the baseline	Baseline through Day 14
percentage of patients who reached the sustained clinical recovery of COVID-19 symptoms in every visit	percentage of patients who reached COVID-19 symptoms scores of 0 for two consecutive days in every visit	Baseline through Day 14
Time to the first negative SARS CoV-2 test result	The time from the start of treatment to the time when the first negative SARS CoV-2 qPCR result showed CT value ≥35	Baseline through Day 14
progression of COVID-19 infection	the percentage of patients who progressed to severe/critical COVID-19 or death from any cause	Baseline through Day 14

Collaborators and Investigators

• Sponsor: Westlake Pharmaceuticals (Hangzhou) Co., Ltd.
• Investigators: Principal Investigator: Hainv Gao, Shulan (Hangzhou) Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Actual): May 9, 2023
• Study Completion (Actual): July 3, 2023

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases
• Other Study ID Numbers: WPV01-CP-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 6 months after summary data has been published, sponsor will share the IPD and additional supporting information after internal approval process.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No